Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02400957
Status:
UNKNOWN
Last Update Posted:
2015-03-27
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017001', 'term': 'Tooth Demineralization'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586932', 'term': 'colloidal silver'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'enamel demineralization (Diagnodent - pen evaluation)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['silver nanoparticles', 'demineralization', 'brackets'], 'conditions': ['Tooth Demineralization']}, 'referencesModule': {'references': [{'pmid': '22900442', 'type': 'RESULT', 'citation': 'Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.', 'detailedDescription': 'Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients candidates for orthodontic treatment.\n\nExclusion Criteria:\n\n* Patients with O.D 11 and / or 21 absent.\n\n * Patients who present dentures of any kind in OD 11 and 21.\n * Patients presenting endodontic OD 11 and 21.\n * Patients presenting data gingivitis day cementing brackets.'}, 'identificationModule': {'nctId': 'NCT02400957', 'briefTitle': 'Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de San Luis Potosí'}, 'officialTitle': 'Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA', 'orgStudyIdInfo': {'id': 'CEI-FE-023-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silver nanoparticles', 'description': 'Half of the mouth was applied silver nanoparticles. Allocation was randomized.', 'interventionNames': ['Other: Silver nanoparticles']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Half of the mouth was applied placebo. Allocation was randomized.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Silver nanoparticles', 'type': 'OTHER', 'description': 'Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.', 'armGroupLabels': ['Silver nanoparticles']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Primer-bond'], 'description': 'Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78210', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Gabriela Moreno Meraz', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'Mauricio Pierdant, Profesor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Autonoma San Luis Potosi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de San Luis Potosí', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MsC', 'investigatorFullName': 'Gabriela Moreno-Meraz', 'investigatorAffiliation': 'Universidad Autonoma de San Luis Potosí'}}}}